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PIVYA

NDA · New Drug Application · Sponsor: ALEMBIC THERAP · Approved 2024-04-24

Drug application

FDA Application #

NDA216483

Application type

New Drug Application

Brand name

PIVYA

Generic name

PIVMECILLINAM

Active ingredients

PIVMECILLINAM HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ALEMBIC THERAP

Manufacturer

Alembic Pharmaceuticals Inc.

First approval

2024-04-24

Source

Authoritative

Drugs@FDA application overview

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